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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828805
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 07/05/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported a certas plus in-line valve was implanted in a patient via ventricular peritoneal shunt several years ago with an unknown initial setting. When the set pressure of the valve could not be changed, the neodymium response was implemented one week prior to the shunt revision, but the set pressure could not be changed. It is unknown if the patient had any clinical signs or symptoms of hydrocephalus. The patient was taken to surgery and the valve was removed and replaced on (b)(6) 2021. The patient is in follow-up. No further information was provided by hospital.
 
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Brand NameCERTAS INLINE VLV W/ SPHNGRD
Type of DeviceCERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12216564
MDR Text Key263099257
Report Number3013886523-2021-00330
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828805
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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